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Roflumilast, a once-a-day oral tablet, would be the first in an entirely new class of treatment for COPD if it receives regulatory approval from the authorities in Europe (EMEA) and the US (FDA).
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The lung function improvements on top of current bronchodilation clearly indicates that roflumilast improves lung function over and above what can be achieved with other COPD treatments alone.
Nausea, diarrhoea and weight loss were the most common adverse events recorded in patients in the four trials, but they were generally mild to moderate in intensity and generally occurred in the first weeks of treatment.